The changing landscape of pharmaceutical medicine.

IN THIS ARTICLE ...

Examine the sweeping changes taking place in pharmaceutical medicine including a new code of conduct, federal regulations and industry changes designed to improve drug companies' standards and elevate their performance.

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Pharmaceutical companies frequently are perceived as exerting too much influence on physician prescribing and education. Loss of credibility--generated by an almost daily barrage of bad publicity that has inundated the pharmaceutical industry--may be the most serious challenge for physician executives working within and with the pharmaceutical industry.

Government regulations and new industry guidelines are changing the pharmaceutical landscape, altering the way drug companies interact with professional audiences. Here's a look at recent developments and their impact with physician executives.

PhRMA code

The Pharmaceutical Research and Manufacturers of America (PhRMA) is an organization that represents research-based pharmaceutical and biotechnology companies. In July 2002, the organization approved its' PhRMA code that focuses on interactions with health care professionals.

Although compliance with the code is voluntary, its two main purposes are to eliminate potentially inappropriate influences on health care prescribing decisions and to minimize any appearance of impropriety. In contrast to the American Medical Association guidelines on gifts to physicians, the focus of the PhRMA code is on the value of the information provided.

The preamble of the PhRMA code openly acknowledges the pharmaceutical industry's concern about the public perception of industry relations with health care professionals. It reads, in part:

"In interacting with the medical community, we are committed to following the highest ethical standards as well as legal requirements. We are also concerned that our interactions with health care professionals not be perceived as inappropriate by patients or the public at large. This code is to reinforce our intention that our interactions with health care professionals are to benefit patients and to enhance the practice of medicine. The code is based on the principle that a health care professional's care of patients should be based, and should be perceived as being based, solely on each patient's medical needs and the health care professional's medical knowledge and experience."

The main points of the PhRMA code address:

* Interactions -- The purpose of interacting with health care professionals is to share scientific and educational information and support medical research to benefit patients.

* Informational meetings -- Meetings should occur at a venue conducive to providing scientific or educational information. The audience should be comprised of professionals (no spouses). Only modest meals or refreshments should be served. Entertainment and recreational events are not permitted.

* Continuing education -- When companies underwrite medical conferences or meetings other than their own, they should not control the content, faculty, educational methods, materials and venue. Companies may provide support to the conference sponsor but should not fund individual participants. However, financial assistance for scholarships or other educational funds to permit trainees to attend carefully selected conferences may be offered as long as the trainees are selected by the academic or training institution.

* Consultants -- Consulting or advisory arrangements must serve a legitimate need of the company. Consultants should be selected and compensated based on their expertise, not as a reward or inducement for prescribing. There should be a sufficient (but not excessive) number of consultants for the specific program. The pharmaceutical company should maintain records of the meeting and make appropriate use of the feedback provided by the consultants.

* Practice-related items -- Health care professionals may receive items primarily for the benefit of patients if the items are valued under $100. Items for the personal benefit of the health care professional should not be offered or distributed. In short, nothing should be offered or provided that would create a conflict of interest or interfere with the independence of the health care professional's prescribing practices.

FDA regulations

The U.S. Food and Drug Administration also regulates promotional programs sponsored by pharmaceutical companies. The underlying theme of the FDA regulations is to ensure that drug promotion is not false or misleading. Physician executives who speak on behalf of pharmaceutical companies must provide fair balance, stay "on label," and be truthful.

Fair balance means that a product's risks and benefits are discussed, including a discussion on safety information such as contraindications, warnings, precautions and adverse effects.

Staying "on label" means that the information provided by a speaker is consistent with the FDA-approved prescribing information that appears in the package insert. The only exception is when answering unsolicited questions on unapproved uses. In such instances, brief answers to questions are permissible.

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"Gang of II"

Eleven of the world's most influential medical journals have taken a stand against drug companies. They're concerned that pharmaceutical firms may keep negative information about their products out of published research studies by limiting what and where the scientists can publish scientific data. This means physicians may never hear about potential problems with the drug.

The editors of the medical journals have issued strict guidelines dealing with the disclosure of conflicts of interest. They will not review articles based on studies that are conducted under conditions that allow the sponsor (pharmaceutical company) to have sole control of the data.

Unless clinical trials can be proven to be independent, the results will not be published to protect patients.

ACCME 

The Chicago-based Accreditation Council for Continuing Medical Education (ACCME) identifies, develops and promotes standards for quality continuing medical education (CME).

Revised standards for commercial support of educational programs may impose even tougher rules regarding conflict of interest related to pharmaceutical companies. The new standards are expected to be approved by the end of this year.

ACCME's intent is to prevent drug companies from offering promotional activities disguised as CME. Although the goal is admirable, ACCME's policies may actually undermine the value of CME by limiting the scope of legitimate educational activities and restricting the participation of physician executives in such activities.

Many of the most talented experts may be prevented from participating in CME because these same experts provide services to the pharmaceutical industry and have financial interests as practicing physicians. However, it is the position of the ACCME that conflicts of interest can be resolved without excluding experts.

Details of the ACCME proposed standards can be found on the ACCME web site at http://www.accme.org. Once approved, the ACCME expects that it will be March or July 2006 before providers will be reviewed under the updated standards.

Medicare

The Medicare Prescription Drug Improvement and Modernization Act was signed into law on December 8, 2003. Medicare now provides seniors and disabled Americans with important benefits that the program did not offer before--an outpatient prescription drug benefit, a "welcome to Medicare" physical exam, cardiovascular and diabetes screenings, disease management programs, incentives for employers to continue offering retiree benefits, and more.

The new drug benefit, Part D of Medicare, begins in January 2006. Until that time, Medicare beneficiaries will have access to the new Medicare-approved discount drug card that enables prescription medicines to be purchased at reduced cost.

As a result of the Medicare pharmacy benefit, there will be an increase in demand for both brand and generic medication. Generic drugs will be speeded to the market by limiting the ability of pharmaceutical companies to block cheaper equivalents. The ban on re-importing prescription drugs from abroad will remain, but such drugs will be allowed from Canada if the Secretary of Health and Human Services certifies their safety--a move that is unlikely to happen.

The new Medicare law is a great step forward for beneficiaries, but it is complex and will be difficult to make operational. The legislation will have tremendous impact on key stakeholders including physician executives. Those wanting more information can go to the U.S. Government Medicare Internet site at http://www.medicare.gov/MedicareReform. The complete legislation (nearly 700 pages) can be accessed at http://waysandmeans.house.gov/media/pdf/hr1/hr1-conflegtext.pdf.

HIPAA 

The Health Insurance Portability and Accountability Act (HIPAA), the federal law designed to protect the privacy of patients' health information, went into effect April 14, 2003. Although HIPAA was intended primarily for health care providers, health plans and health care clearinghouses, it has significant implications for pharmaceutical companies.

For example, it is often necessary to obtain the patient's approval before sending promotional and educational material about treatment options. HIPAA may rule out the use of many databases created before the law was enacted, since patients are unlikely to have granted permission to have their identities disclosed.

However, HIPAA also provides exemption for the disclosure and use of protected health information without prior authorization to those who are subject to the jurisdiction of the FDA, such as a pharmaceutical manufacturer, for public health purposes related to the quality, safety, or effectiveness of FDA-regulated products.

This exemption allows the gathering and reporting of information related to adverse events associated with the use of FDA-regulated products without violating the HIPAA privacy rule.

Enforcement of the HIPAA privacy rule is compliance-driven, so physician executives employed by pharmaceutical companies and those working in a consulting capacity to the industry must have a complete understanding of HIPAA in order to help maintain compliance.

Detailed information about HIPAA can be found at http://www.hhs.gov/ocr/hipaa.

Industry response

In response to increasing regulation and mounting negative publicity and criticism, the pharmaceutical industry is undergoing sweeping changes. Companies are taking strides to offer highly effective and innovative medicines, as determined by large, well-tested and well-designed clinical trials that are free of bias.

Standards governing research sponsorship, authorship and accountability are being tightened to improve scientific objectivity. Advertising is being scrutinized to ensure that marketed products have credible claims. Sales representatives are receiving extensive scientific training and training in ethics.

Many companies are rededicating themselves to scientific discovery and exploring novel mechanisms of drug action in addition to seeking clinically significant improvements in established compounds. These are areas where physician executives can surely contribute to the future of pharmaceutical medicine.

By Arthur Lazarus, MD, MBA, CPE, FACPE 

Arthur Lazarus, MD, MBA, CPE, FACPE, is senior director of clinical research for AstraZeneca Pharmaceuticals based in Wilmington. Del. He is a frequent contributor to The Physician Executive and editor of MD/MBA: Physicians on the New Frontier of Medical Management (American College of Physician Executives, 1998). He can be reached at 302-885-4542 or [e-mail]. His opinions are not necessarily those of AstraZeneca, its management, agents or employees.

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